The starting point in creating a quality monitoring process is using a systematic approach. This course trains the CRA on MRM's three step monitoring method to facilitate consistency and standardization in performing the monitoring responsibilities. Another important aspect of monitoring is learning how to bring a non-compliant investigator into compliance using Corrective Action and Preventative Action (CAPA) plans and documenting such plans in a professional and effective monitoring report and follow-up visit correspondence. This 3 day course is enhanced by the hands-on training that utilizes simulated case studies, an investigator study file, and report writing exercises. These techniques can be applied to all studies whether they are drug, device, or biologic. MRM provides each participant with a CD-ROM regulatory reference.

This course is designed for individuals with a minimum of 6 months clinical research experience or CRAs who have not had any formal training and want to learn skills that will enhance their monitoring activities.

Cancellations by registrants must be
provided in writing prior to the start date of the seminar,
such registrants shall receive a credit voucher toward
a future MRM seminar. Companies may substitute someone
registered with another participant at any time. MRM reserves
the right to cancel a seminar due to poor enrollment or
acts of nature and shall not be responsible for any airfare,
hotel, or other costs. MRM shall offer a credit voucher
to a future seminar or a complete refund for MRM Seminar
cancellations. Seminar topics and speakers may be subject
to change without any prior notice.